Search Results

The Medline UNITE® Ankle Fusion Plating System is indicated for use in arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodesis, in conjunction with stabilization of fresh fractures, revision procedures, and reconstruction of bones in the feet and ankles.

The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® Ankle Fusion Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device. The system can be used in both adult and pediatric (adolescent and child) patients.

Medline UNITE® Ankle Fusion Plates and Screws used for the surgical treatment of pediatric patients should not cross an active growth plate as this may impede bone growth and development in skeletally immature patients. Implanted Medline UNITE® Ankle Fusion Plates and Screws which span an active growth plate in a pediatric patient. should be considered for hardware removal after primary arthrodesis or bone healing has been achieved.

The Medline UNITE® Ankle Fusion Plating System Plates and Screws are manufactured from Titanium Alloy (Ti-6A1-4V ELI). The system includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 4.5mm and 5.5mm diameter locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots included in the plates. Additionally, several plates in the system can accommodate 3.5mm and 4.0mm locking and non-locking cortical screws. Previously cleared 3.5mm (K151235) and 4.0mm locking and non-locking cortical screws, ranging from 16-40mm will be included in the tray with the Medline UNITE® Ankle Fusion Plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drills, drill guides, tissue protectors, targeting guides, targeting guide sleeves, and a tray.

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) premarket notification for a medical device (Medline UNITE® Ankle Fusion Plating System) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical (bench) testing.

The document explicitly states:

• "This section does not apply. No animal testing was performed."
• "This section does not apply. No clinical testing was performed."
• "Summary of Clinical Testing: Not applicable."

Therefore, there is no information regarding:

• Acceptance criteria and reported device performance related to a clinical study.
• Sample size used for the test set or its data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical study.
• Sample size for the training set.
• How ground truth for the training set was established.

Ask a specific question about this device

The Stratum Ankle Fusion Plating System is indicated for use in stabilization of fractures or osteotomies, intra and extra articular fractures, and multi-fragmentary fractures, non-union and malunion, joint fusion and reconstruction of small bones of the feet and ankles including the distal tibia, talus, and calcaneus.

The Stratum Ankle Fusion Plating System is a foot and ankle plating system consisting of plates and screw implants. The plates are 3.5mm thick, range in length from 73.66mm to 107.70mm, and range in width from 22.10mm to 40.64mm. The plates have between 10 and 13 locking screw holes and 1 to 2 slots. The plates are provided sterile. The system provides locking and nonlocking screws that are available in diameters of 3.5mm and range in length from 10mm to 80mm. The screws are provided sterile and non-sterile. The system includes cannulated crossing screws that are 6.5mm in diameter and range from 26mm to 90mm in length. The cannulated screws are provided sterile. The plates and screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136.

The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.

This document is lacking the essential information requested in the prompt, such as acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy, AUC), sample sizes for test and training sets, details on expert ground truth establishment, adjudication methods, and explicit mention of standalone or MRMC studies.

The provided text describes a 510(k) premarket notification for a medical device called the "Stratum Ankle Fusion Plating System." This is a metallic bone fixation appliance, and the FDA has determined it is substantially equivalent to legally marketed predicate devices. The document focuses on regulatory compliance, device description, indications for use, and non-clinical testing to demonstrate mechanical equivalence. It explicitly states that clinical testing was not necessary for substantial equivalence.

Therefore, I cannot fulfill the request as the provided text does not contain the required information about acceptance criteria, performance studies (clinical or AI-related), sample sizes, expert ground truth, or adjudication methods. The device is a physical bone fixation system, not a software or AI-based diagnostic device that would typically undergo such performance evaluation.

Ask a specific question about this device

The In2Bones Ankle Fusion plating system is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.
The addition of a compression screw through the tibiotalar joint (example IBS™ 6.5mm screw) is required.

The Ankle Fusion Plating System is composed of an anatomically contoured plate, with a distal part adapted to the talar neck, and a proximal part adapted to the distal tibial epiphysis and diaphysis. Rigid fixation is achieved by screws.
The Ankle Fusion Plating System implants (plate and screws) are manufactured from Ti6Al4V. A dedicated instrument set is available for the bone preparation, screw sizing and insertion of the Ankle Arthrodesis Plating System. A specific targeting device is available for the insertion of the additional I.B.S® 6.5mm screw.
Sizes: The Ankle Fusion Plate is available in one size, with left and right versions. Fixation screws are available in 3.5 or 4.5mm diameter, with length ranging from 10 to 100mm.
Material: The Ankle Fusion Plating System implants (plate and screws) are manufactured from Ti6Al4V, as per ISO 5832-1 and ASTM F136.
Single use: The Ankle Fusion Plating System is designed for single use only.
Sterilization: The Ankle Fusion Plating System is supplied sterile, using gamma irradiation.
Place of use: The Ankle Fusion Plating System is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.

I am sorry, but the provided text does not contain the detailed information needed to answer your request regarding acceptance criteria and a study proving device performance on an AI/ML device.

The document is a 510(k) premarket notification letter from the FDA for an "Ankle Fusion Plating System," which is a metallic bone fixation appliance, not an AI/ML device.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size and data provenance for an AI/ML test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for an AI/ML test set.
5. Multi-reader multi-case comparative effectiveness study results for AI assistance.
6. Standalone performance of an algorithm.
7. Type of ground truth for an AI/ML device.
8. Sample size for an AI/ML training set.
9. How ground truth for an AI/ML training set was established.

The "Summary Performance Data" section in the document broadly states: "Performance testing of the Ankle Fusion Plating System was assessed through mechanical bench testing performed by an independent test laboratory, animal and clinical testing being considered not applicable. Testing performed included static and dynamic compression tests on Ankle Fusion Plating System. The results indicate that the Ankle Fusion Plating System met the acceptance criteria." This refers to mechanical testing of a physical implant, not an AI/ML system.

Ask a specific question about this device

The ORTHOLOC® 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodessis, in conjuction with osteotomies of the distal tibia, talus, and calcaneus.

ORTHOLOC® Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The subject Universal Anterior Plate is designed to facilitate arthrodesis of the ankle and is composed of titanium alloy. The plate features poly-axial locking screw holes and one compression slot. It accepts screws of multiple diameters and lengths.

The provided text is a U.S. FDA 510(k) premarket notification document for a medical device. This type of document is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device.

The document does not describe the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device or a diagnostic device. It is for a mechanical orthopedic implant (an ankle fusion plating system).

The "study" referenced in this document is a "non-clinical" engineering analysis (Finite Element Analysis and cross-sectional analysis) rather than a clinical trial or performance study against specific acceptance criteria for diagnostic output.

Therefore, most of the information requested in your prompt (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, ground truth, MRMC study, standalone performance) is not applicable or not present in this document because it pertains to a different type of medical device evaluation.

However, I can extract the relevant information from the document as best as possible, focusing on how substantial equivalence was demonstrated:

1. Table of Acceptance Criteria and Reported Device Performance

For this orthopedic implant, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to a predicate device in terms of mechanical performance. The study aimed to show that the new device's bending strength was comparable to the predicate and did not introduce a new worst-case scenario.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. The "test" here refers to non-clinical engineering analysis (Finite Element Analysis and cross-sectional analysis), not a traditional clinical sample size or dataset for diagnostic performance.
• Data Provenance: Not applicable. As an engineering analysis, it relies on material properties, design specifications, and computational models, not patient data from a specific country or retrospective/prospective studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth, in the context of diagnostic performance, is not relevant for this mechanical engineering analysis.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, not a diagnostic tool evaluated by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

Not applicable. For a mechanical device evaluated through engineering analysis, "ground truth" as typically understood in diagnostic studies (e.g., pathology, outcomes data, expert consensus) is not applied. The "truth" is established by the laws of physics and engineering principles applied in the analysis.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a mechanical device evaluated through engineering analysis, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no "training set" or "ground truth" in the context of an engineering analysis for a mechanical device.

Summary of the Study for Substantial Equivalence:

The study performed was a non-clinical evaluation consisting of:

• Finite Element Analysis (FEA)
• Cross-sectional analysis

These analyses were conducted to compare the bending strength of the new ORTHOLOC® 3Di Universal Anterior Plate to its predicate device (K121425: ORTHOLOC® 3Di Ankle Fusion Plating System). The conclusion was that the new plate demonstrated substantial equivalence in bending strength and did not introduce a new worst-case scenario into the system. This type of evaluation is standard for demonstrating the safety and effectiveness of mechanical orthopedic implants for 510(k) clearance, rather than the clinical performance studies typically required for AI/ML or diagnostic devices.

Ask a specific question about this device

The Arthrex Ankle Fusion Plating System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, and fibula.
The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plating System.

The Arthrex Ankle Fusion Plating System is a family of implantable titanium plates and screws intended to be used for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, and fibula.
The subject plates are contoured and may be available in left and right configurations, ranging in length from 91.9mm to 133.6mm. The accompanying screws are solid or cannulated, fully or partially threaded, and may be locking or non-locking. The proposed screw offering subject of this application are 4.5mm to 6.7mm in diameter and 16mm to 120mm in length and include the partially threaded cannulated lag screws and 13mm washer previously cleared in K123241.
The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex, Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plating System.

The provided text describes a 510(k) premarket notification for the Arthrex Ankle Fusion Plating System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics against ground truth. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and ground truth establishment is not present in the provided document.

Here's a breakdown of what can be extracted, and where the requested information is absent:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail metrics. The submission aims to demonstrate "substantial equivalence" to the predicate device.
• Reported Device Performance: The document states: "mechanical testing data demonstrates that the four-point bending, pull-out and insertion torque strength of the proposed Arthrex Ankle Fusion Plating System devices are substantially equivalent to or better than the four-point bending, pull-out and insertion torque strength of the predicate devices." No specific numerical values or comparison data are provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not present in the provided document. The device is a physical orthopedic implant, and the evaluation mentioned is mechanical testing, not a clinical study involving human patients where "test set" and "data provenance" would be applicable in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not present. Ground truth in the context of mechanical testing would refer to established engineering standards or the performance of the predicate device, not expert human assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not present. Adjudication methods are typically used in clinical studies where human interpretation of data is involved, which is not the primary focus of this 510(k) summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This information is not present. This is a medical device for bone fixation, not an AI or imaging diagnostic tool. An MRMC study is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This information is not present. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For a 510(k) submission of a bone fixation device, the "ground truth" for demonstrating substantial equivalence is typically based on mechanical testing against established engineering standards or the performance of the predicate device. The document refers to "mechanical testing data" for "four-point bending, pull-out and insertion torque strength."

8. The sample size for the training set

• This information is not present. A "training set" is relevant for machine learning algorithms, not for physical medical implants undergoing mechanical testing for substantial equivalence.

9. How the ground truth for the training set was established

• This information is not present for the same reason as point 8.

In summary, the provided document is a 510(k) summary for a bone fixation device, which focuses on demonstrating substantial equivalence through mechanical testing rather than presenting a clinical study with detailed acceptance criteria, ground truth establishment, or clinical performance metrics as would be seen for a diagnostic or AI-driven device.

Ask a specific question about this device

Wright's ORTHOLOC™ 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodeses, in conjunction with osteotomies and fractures of the distal tibia, talus, and calcaneus.

ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

ORTHOLOC™ 3Di Ankle Fusion Plating System: The ORTHOLOC™ 3Di Ankle Fusion Plating System contains 22 plates belonging to 1 of 3 general categories based on the contouring of each plate and intended surgical approach. All plates feature poly-axial locking screw holes and one or two compression slots. The plates are made from titanium alloy conforming to ASTM F136 or ISO 5832-3 and accept 4.5mm and 5.5mm ORTHOLOC™ 3Di locking screws, 4.5mm and 5.5mm ORTHOLOC™ Fully Threaded Bone Screws, and 5.5mm ORTHOLOC™ Partially-Threaded Bone Screws. Washers of the same material are also available for use with the ORTHOLOC™ Bone Screws.

ORTHOLOC™ Bone Screws: ORTHOLOCTM Bone Screws are cancellous or cortical, partially or fully threaded non-locking screws offered in various diameters and lengths. All screws are manufactured from ASTM F136 or ISO 5832-3 titanium alloy and intended for single use only. These screws are intended to be used with the appropriately sized washers to prevent the screw head from breaking through the cortex of the bone by distributing the forces/loads over a large area.

The provided document, K121425 for the ORTHOLOC™ 3Di Ankle Fusion Plating System and ORTHOLOCTM Bone Screws, describes non-clinical evidence for substantial equivalence, primarily focusing on mechanical testing rather than a clinical study or AI-based performance. Therefore, many of the requested elements for AI-based device evaluation (like sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance with AI) are not applicable or not explicitly detailed in this 510(k) summary.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not explicitly stated as this was mechanical testing of device components, not a clinical study on patient data.
• Data Provenance: The data is generated from in vitro mechanical testing of the physical device components (plates and screws). There is no patient data involved from specific countries or retrospective/prospective studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable. This submission relies on engineering and mechanical testing, not a ground truth established by human experts interpreting clinical data for diagnosis or treatment decisions. The "ground truth" or acceptance criteria for mechanical properties would be established by engineering standards and internal specifications, likely vetted by qualified engineers.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is mechanical testing, there is no human interpretation of images or clinical data that would require an adjudication method. The results are quantitative measurements against pre-defined engineering thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC study was not done. This submission is for a medical implant (bone plates and screws) and primarily relies on mechanical performance testing for substantial equivalence, not on the interpretation capabilities of human readers, with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not Applicable. This is not an AI algorithm. The device is a physical surgical implant.

7. The Type of Ground Truth Used:

• The "ground truth" for the mechanical performance testing would be the established engineering specifications, ASTM or ISO standards, and internal design requirements for strength, locking mechanism efficacy, and pullout resistance for bone plates and screws. These are quantifiable, objective physical properties.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As there is no training set for an AI algorithm, this question does not apply.

Ask a specific question about this device